Allergan plc, a leading global pharmaceutical company, announced that Viberzi (eluxadoline), the company's first-in-class treatment for irritable bowel syndrome with diarrhoea (IBS-D), is now available by prescription in the US.
"We are excited about the launch of twice daily Viberzi, which addresses an unmet need among IBS-D patients seeking a treatment to manage their symptoms proactively," said William Meury, president and executive vice president, branded pharma at Allergan. "This introduction reaffirms Allergan's commitment to providing a new treatment option that serves to help gastroenterologists reach better outcomes for their patients."
IBS-D is a multifactorial disorder marked by recurrent abdominal pain or discomfort and diarrhoea that affects as many as 15 million adult Americans, impacting both women and men equally. There are few prescription treatment options available for IBS-D, particularly options that relieve both the diarrhoea and abdominal pain associated with IBS-D.
Viberzi is an oral medication that relieves the core symptoms of IBS-D, diarrhoea and abdominal pain. Symptom relief was maintained throughout treatment in two pivotal clinical trials.
On November 12, 2015, the Drug Enforcement Agency (DEA) completed its review of Viberzi, and published its Final Rule placing Viberzi into Schedule IV of the Controlled Substance Act. Schedule IV drugs, substances, or chemicals are defined by the DEA as drugs with a low potential for abuse and low risk of dependence.
IBS-D is a functional bowel disorder characterized by chronic abdominal pain and frequent diarrhoea, which affects approximately 15 million patients in the US. Although the exact cause of IBS-D is not known, symptoms are thought to result from a disturbance in the way the gastrointestinal tract and nervous system interact.
IBS-D can be debilitating and there are limited therapeutic options for managing the chronic symptoms. IBS-D is associated with economic burden in direct medical costs and indirect social costs such as absenteeism and lost productivity, along with decreased quality of life.